Drug reviewers said Edwards Lifesciences’ heart valve “demonstrated superiority” in a trial that also showed the device’s safety and effectiveness for patients considered to be too sick to have open-heart surgery. The trial, however, also showed people were at a high risk of stroke after using the heart valve, and the reviewers, in documents released on Monday, said neurological adverse effects remained an important safety consideration for the device. A panel of FDA advisers will review the data on the heart valve on Wednesday and the reviewers specifically asked the panel to weigh the device’s benefits versus risks.
